Personalizing Immune Checkpoint Inhibitor Therapy for Solid Tumors
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Anti-tumor immune response
研究概览
简要总结
This prospective, observational study will evaluate whether vitro testing of tumor tissue and white blood cells from patients with lung cancer who are being treated with immune checkpoint inhibitors and other standard of care approaches, predicts clinical response to these agents.
详细描述
Overall Goal: The long-term goal of this study is to predict whether checkpoint inhibitors will be effective in individual patients with solid tumors.
Objectives: In this pilot study to be conducted in ten subjects with lung cancer who are to receive checkpoint inhibitors, we will use cellular and molecular techniques to characterize
- tumor immunogenicity
- anti-tumor T-cell response
- effect of checkpoint inhibitors on antigen presentation and T-cell response, and
- the tumor microenvironment
Planned enrollment:
• Ten subjects with lung cancer
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with lung cancer about to undergo diagnostic/excisional biopsy with the intent to receive therapy with immune checkpoint inhibitors
- •Availability of fresh tumor tissue removed at excisional biopsy or diagnostic biopsy
- •Informed consent
排除标准
- •Lack of informed consent
结局指标
主要结局
Anti-tumor immune response
时间窗: 12 months
Tumor antigen presentation and anti-tumor T-cell response
次要结局
- Tumor microenvironment(24 months total study duration)
- Clinical response(12 months for each subject)